The success of new drug products depends on their pharmacoeconomic value

Industry, payer and analyst experts agree: Pharmaceutical and biotechnology companies must incorporate pharmacoeconomic value into development and brand strategy decisions to remain competitive

NEW YORK, June 15, 2005—Pharmaceutical and biotechnology companies are putting their revenues at risk by failing to appropriately address the healthcare value needs of private and public managed care payers, according to the expert panel at American Management Association’s (AMA) Webcast, Establishing Healthcare Value: New Tactics for Brand Survival and Corporate Competitiveness in May.

With increasing healthcare costs on one side and employers rejecting continued insurance premium increases on the other, managed care organizations (MCOs) are being squeezed, having little choice but to find ways to utilize healthcare resources more efficiently than ever. According to Richard Fry, Director of Programs at The Foundation for Managed Care Pharmacy (FMCP), many MCOs are controlling rising pharmaceutical and biologicals costs by adding to formularies only those therapeutics that manufacturers can prove deliver improved patient healthcare outcomes while favorably impacting overall treatment costs relative to the standard of care. This outcomes-based access (OBA) system requires that manufacturers prove to payers that their products offer compelling pharmacoeconomic value, or face coverage rejection.

“Using the best available published and unpublished clinical and economic data, including cost-effectiveness analyses and pharmacoeconomic models, MCOs may reject for coverage and reimbursement clinically effective therapies that cannot demonstrate meaningful healthcare value, compared to available alternative treatments,” Fry said. While payers are willing to pay for new therapies that come at a greater acquisition cost, the new interventions must deliver superior patient outcomes, such that payers can justify their overall financial burden on the healthcare system in comparison to the current standard of care.

The public sector is lagging behind the private sector in adopting an evidence-based medicine approach, according to Joan Henneberry, Senior Vice President at Policy Studies Inc., consultants to health, human services and justice organizations, and former director of the Health Policy Studies Division, Center for Best Practices at the National Governors Association. She pointed out that Medicare faces a major funding crisis that at some point is likely to require an approach that utilizes limited healthcare resources more efficiently. “Employers are really paving the way advocating for value in purchasing, but I do think that the public sector will follow the private sector down the road,” Henneberry said.

Value-based coverage evaluations must be taken into account early. Seamus Fernandez, Vice President and equity analyst at SG Cowen & Co., a leading healthcare investment bank, indicated that outcomes-based access requires manufacturers to be more aggressive in their development targets. He indicated that it is no longer possible for manufacturers to build development strategies around reformulations and “me-too” products because payers will not pay for them. “Manufacturers need to seek aggressive targets in major disease areas that change the standard of care, as well as target under served disease areas,” Fernandez said. He indicated that Wall Street increasingly is valuing pharma and biotech companies based on assessments of companies’ product development strategies, favorably valuing those that have meaningfully incorporated pharmacoeconomic value as a key development goal alongside safety and efficacy.

According to Michael Russo, Partner at The Bruckner Group, strategy and research consultants for the pharmaceutical and biotechnology industries, the U.S. healthcare system has not adequately developed the strategic skills and insights required to address outcomes and value-based decision making. “Defining and developing value in a specific disease area is a tricky business, requiring a change in market orientation and experience in such evaluations.” Russo believes that “most pharma and biotech companies are still struggling to understand how outcomes-based access impacts their development and marketing strategies. Many do not even have a US managed-markets group, and for those that do, it is under staffed, and under funded. Those relatively few pharma and biotech companies that are responding effectively to OBA have strong executive leadership that recognizes that pharmacoeconomic focus is mission-critical, across the entire enterprise, not just in a specialty outcomes research group.”

Russo further indicated that while some manufacturers have responded to OBA by focusing primarily on product pricing and launch strategies that include additional services, a proper response to OBA requires activities in all aspects of the product life cycle. Those companies that recognize this reality and respond accordingly will be the next generation of successful pharma and biotech companies.

AMA and The Bruckner Group offer training programs that address major marketing, pharmacoeconomic and sales challenges currently faced by pharmaceutical and biotechnology manufacturers. The programs are divided into three broad categories: basic skills training in pharmacoeconomics, market research and analytical techniques; applying fundamentals to the sales, marketing and branding challenges in the pharma industry, including strategic marketing efforts and physician detailing; and overviews of the pharmaceutical industry and drug development process.

About AMA
American Management Association is the world’s leading membership-based management development organization. For 80 years, it has provided valuable and practical action-oriented learning programs to people at all levels, in all industries, from companies and agencies of all sizes. More than 500,000 AMA customers and members a year learn new skills and behaviors, gain more confidence, advance their careers and contribute to the success of their organizations through a wide range of AMA seminars, conferences and executive forums, as well as through AMA books and publications, research and print and online self-study courses.

About The Bruckner Group
The Bruckner Group Inc. (BGI), located just outside of Boston in Wakefield, Massachusetts, is a strategy and research firm exclusively serving the pharmaceutical and biotechnology industries. BGI operates at the intersection of clinical medicine and competitive strategy, using highly quantitative and data-intensive approaches to develop brand strategies and perform research and analysis. BGI’s singular goal is to develop solutions that maximize the revenue generation of clients’ therapeutic innovations. BGI is the leading expert in outcomes-based access (OBA). BGI’s OBA practice helps manufacturers maximize product revenues by properly developing, marketing and building competitive advantage on the basis of the comparative healthcare and pharmacoeconomic value of therapeutics. For more information, visit www.brucknergroup.com.

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